A Phase Ib Study of Cryoablation and Pressure-enabled Hepatic Arterial Infusion of Class C Toll-like Receptor 9 Agonist SD-101 in Combination With Durvalumab and Tremelimumab in Patients With Advanced Hepatocellular Carcinoma
University of California, San Diego
Summary
The goal of this Phase 1b clinical trial is to evaluate the safety and efficacy of cryoablation and hepatic arterial administration of SD-101 in participants with advanced hepatocellular carcinoma. After this procedure, participants will be treated with tremelimumab and durvalumab every 4 weeks (STRIDE regimen).
Description
This is a phase I, single site study to determine the safety, tolerability, and efficacy of cryoablation combined with hepatic arterial administration of SD-101 in participants with advanced hepatocellular carcinoma (HCC). After this procedure, participants will be treated with tremelimumab and durvalumab every 4 weeks (STRIDE regimen). SD-101 (also called nelitolimod) is a CpG oligodeoxynucleotide (CpG-ODN). More specifically, SD-101 is a bacterial DNA fragment that functions as a toll-like-receptor 9 (TLR9) agonist on myeloid-derived suppressor cells (MDSC), plasmacytoid dendritic cells (pD…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willing and able to provide written informed consent prior to performance of any study- specific procedures. * Age ≥ 18 years. * Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants: 1. For cirrhotic participants with no histological confirmation of diagnosis, clinical confirmation is required per AASLD criteria. 2. Pathological diagnoses of HCC will be made according to the Inter…
Interventions
- DrugSD-101
Toll-like receptor 9 (TLR9) agonist
- DeviceCryotherapy
Cryoablation of liver
- DrugTremelimumab
Anti-CTLA4
- DrugDurvalumab
Anti-PDL1
Location
- University of California, San DiegoSan Diego, California